Lead Engineer

This is afull-time salaried position withProject Farma,a PerkinElmer company. The successful candidate willresidein one of Project Farma's primary markets and bewilling to travel domesticallyto meet client projectrequests.

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Project Farma’s purpose is toimprove patient lives by acceleratingthe delivery of life-changingtherapies.Weaccomplishthisthrough thesuccessful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) teammemberscollaboratewith cross-functional teams to build trusted client relationships, deliveran exceptional customer experience, andcontributeto business growth byidentifyingopportunities and applying data-driven insights to support project planning, cost, schedule, and performance management. 

All team members are expected to embody Project Farma’s values by beingcurious,personable, andunselfish, whilemaintaininga strong commitment to aPatient Focused and People First mindset.

TheLeadEngineeris an advanced individual contributor with demonstrated depth in their technical discipline and a growing record of leading complex workstreams. This role applies strong subject‑matterexpertiseto solve high‑impact technical and operational challenges, supports technical decision‑making, and contributes to the evolution of standards, methods, or best practices within their area.They partnerclosely with project and people leaders—whileremainingfocused on technical delivery rather than formal people management.

Key Responsibilities

The Automation Engineer provides subject matterexpertisein the design, implementation, and lifecycle management of automation systems across biologics, pharmaceutical, and novel therapy manufacturing facilities. This role requires deep experience withDCS/PLC/BMS/EMSplatforms and the ability to author, interpret, and lead documentation such asURS,FRS,Functional Narratives, and detailedsystem architecture designs.

Automation Design & Architecture

• Developfull automation system architecturesfor biologics, pharmaceutical, and advanced therapy manufacturingfacilities(DCS, PLC/SCADA, MES, historians, network layers, field instrumentation).

• CreateISA‑88/ISA‑95‑aligned architecture diagrams, I/O strategies, network topologies, and interface specifications.

• Ensure architecture supports scalability, cybersecurity, data integrity, and multi‑product flexibility.

​URS / FRS / Design Documentation

Lead the creation, review, and approval of: 

• URS(User Requirements Specifications)

• FRS(Functional Requirements Specifications)

• DS / DDS(Design Specifications)

• Functional & Control Narratives

• Recipe Design Documentation(ISA‑88 compliant)

• Automation Standards & Engineering GuidelinesWork cross functionally to translate process requirements into robust automation design documents.

Automation Implementation

• Configure, program, and deployDCS/PLC(modules, phases, recipes, batch strategies, graphics, alarms).

• Support integration of OEM skids: bioreactors, chromatography systems, filtration skids, CIP/SIP, and fill finish equipment, HVAC, Chillers, Boilers, etc.

Commissioning, Validation & GMP Compliance

• Detailed knowledge ofFAT,SAT,IQ/OQ, andPQprotocols in alignment with GAMP 5 and 21 CFR Part 11.

• Ensure automation changes meet data integrity requirements, change control processes, andvalidationlifecycle rules.

• Lead deviation investigations, CAPAs, and risk assessments related to automation systems.

Manufacturing & Operations Support

• Serve as SME for troubleshooting, system optimization, alarm tuning, batch failure analysis, and performance enhancements.

• Support 24/7 operations through structured root cause analysis and resolution of automation issues.

• Develop long-term automation lifecycle plans for upgrades, patches, and system expansions.

Cross Functional Leadership‑Functional Leadership

• Collaborate with IT/OT, process engineering, quality, and capital project teams to deliver integrated automation solutions.

• Manage vendors, system integrators, and OEMs; review design packages and ensure alignment with internal standards.

• Mentor junior engineers and act as technical SME during audits and regulatory inspections.

Attributes for Success

• Technical Delivery: Applies advanced technical knowledge and professionalexpertise

• Innovation & Continuous Improvement: Seeks better ways, adapts to change and championsnew ideas. 

• Customer Focus & Professionalism:RepresentsPF with consistent professionalism,appropriate escalationand respect for internal stakeholders, even during high stress delivery situations 

• Integrity & Humility:Demonstratesself-awarenessand puts PF mission above ego

• Collaboration & Communication:Communicates clearly and proactively and drives transparent alignment with clients.

• Project Execution: Delivers reliably, managesprioritiesand drives forhigh qualityoutcomes 

• Growth Mindset: Shows openness tonew ideas,feedbackand change

Experience Required

• Education:Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up,CapEx/OpExproject management and/or comparable military experience. 

• Strong understanding of ISA‑88 batch control, ISA‑95 manufacturing hierarchy, BACnet, ISO 16484and GAMP 5.

• PLC/DCS4+ years / 7+ yearsin automation engineering within GMP life sciences (biotech, pharma, ATMP). Expert-level experience withDeltaVDCS and/or Rockwell / Allen Bradley PLC/SCADA platforms.

• BMS/EMS4+ years / 7+ yearsinbuildingautomation engineering within GMP life sciences (biotech, pharma, ATMP). Expert-level experience with common BMS and EMS platforms (SiemensDesigoCC, Rockwell PLC,Schneider Electric,etc)

• Willingness to travel asrequiredfor client project assignments.

Other Preferred

• Strongcommunicatorandinfluenceracross engineering, quality, IT/OT, and manufacturing.

• Structured thinker with advanced troubleshooting and problem-solving skills.

• Skilled at managing multiple priorities in a high pressure, regulated environment.

• Ability to manage scope and track project changes 

• Demonstrated leadership and mentorship abilities.